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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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30 October 2023 |
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Main ID: |
ChiCTR2200057578 |
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Date of registration:
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2022-03-15 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Tofacitinib treatment in patients with primary Sjogren syndrome: a prospective pilot trial
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Scientific title:
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Tofacitinib treatment in patients with primary Sjogren syndrome: a prospective pilot trial |
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Date of first enrolment:
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2022-03-01 |
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Target sample size:
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Control group:60;Intervention group:60; |
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Recruitment status: |
Pending |
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URL:
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https://www.chictr.org.cn/showproj.html?proj=151237 |
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Study type:
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Interventional study |
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Study design:
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Cohort study
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Phase:
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4
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Countries of recruitment
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China
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Contacts
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Name:
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Zhang Jin
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Address:
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57 Xingning Road, Yinzhou District, Ningbo, Zhejiang
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Telephone:
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+86 13486089482 |
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Email:
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751860714@qq.com |
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Affiliation:
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Ningbo Medical Center Lihuili Hospital |
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Name:
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Chen Jiayuan
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Address:
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57 Xingning Road, Yinzhou District, Ningbo, Zhejiang
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Telephone:
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+86 13567431823 |
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Email:
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chenjiayuan1991921@163.com |
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Affiliation:
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Ningbo Medical Center Lihuili Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. All patients fulfilled the 2002 American-European Consensus Group classification criteria or 2016 ACR/EULAR Consensus Group classification criteria;
2. All patients still showed oral dryness and xerophthalmia after a 6-mouths treatment of hydroxychloroquine sulfate.
Exclusion criteria: 1. Patients with the existence of other connective tissue diseases;
2. Acute sialadenitis, or existence of a relevant, active infection, hepatitis B or C, tuberculosis, HIV or other immunodeficiency, malignancies within 5 years prior, recent organ transplant;
3. Serious cardiovascular diseases, kidney, liver, and other important organ damage, Serious diseases of the blood system and endocrine system;
4. Severe intercurring neurological or psychiatric disease;
5. Pregnancy/lactation and unwillingness to use contraception throughout the study.
Age minimum:
15
Age maximum:
70
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sjogren Syndrome
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Intervention(s)
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Control group:Same dose of hydroxychloroquine sulfate as before;Intervention group:Tofacitinib 5mg bid po+the same dose of hydroxychloroquine sulfate as before;
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Primary Outcome(s)
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Unstimulated whole saliva flow;Stimulated whole saliva flow;Schirmer test;Corneal fluorescence staining;Tear break-up time;EULAR Sjogren's Syndrome Patient Reported Index (ESSPI) Score;EULAR Sjogren's syndrome (SS) disease activity index (ESSDAI) Score;
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Secondary Outcome(s)
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XI Score;COD Score;Chinese version of the symptom assessment in dry eye (SANDE) score;Blood routine examination;Erythrocyte sedimentation rate;Immunologic function;
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Source(s) of Monetary Support
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Hisun biopharmaceutical.CO.,Ltd
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Ethics review
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Status: Approved
Approval date: 30/11/2021
Contact:
Zhang Pei
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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